Originally Published MDDI January 2006
CDRH announced plans to improve safety monitoring of implantable cardioverter defibrillators (ICDs) after a study showed that the number of removed and replaced ICDs has increased in recent years. These plans are part of an effort to beef up postmarket surveillance.
FDA conducted a retrospective review of pacemaker and ICD malfunctions between 1990 and 2002. Although the pacemaker malfunction replacement rate was 4.6 per 1000 implants, the ICD rate was 20.7 per 1000. And while the pacemaker rate decreased during the latter half of the study period, the ICD rate increased during that time.
Among the steps CDRH will take to address the issue is to form a working group tasked with improving communication about ICDs within the center. The goal is for information about problems with ICDs to be quickly evaluated by CDRH staff and shared with the public as soon as possible.
Another goal is to better coordinate OEM annual report information within CDRH. This should make review of postmarket issues more efficient. A guidance covering how best to provide information in postmarket reports to ensure quick review is being developed.
CDRH is also changing how it handles condition-of-approval (CoA) studies. The Office of Surveillance and Biometrics (OSB) will take charge of overseeing the studies. That task now falls to the Office of Device Evaluation (ODE), which is stretched thin trying to get decisions made rapidly.
At October's meeting of the Regulatory Affairs Professionals Society (RAPS), industry got a good look at how these and other efforts are expected to strengthen CDRH's oversight of postmarket issues. A panel on CoA studies was heavily attended and infused with debate.
FDA's involvement with postmarket issues will in fact begin in the premarket phase, when epidemiologists from OSB will examine applications. They will identify crucial questions that may need to be answered in a postmarket study, said Tom Gross, CDRH's director of postmarket surveillance. If a CoA study is deemed necessary, OSB will help the sponsor design it.
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